Curing the Pains Caused by Forms
It is well known that API molecules may exist different solid forms, including polymorph, hydrate, solvate, salt, cocrystal and non-crystalline form. Various solid forms, due to difference in crystal structure, show significant different physicochemical properties that impact the performance of drug products. It is critical to timely identify and select the right solid form with acceptable solid-state properties, such as crystallinity, hygroscopicity, solubility, stability and processability process development, formulation design, and regulatory filing. Drug developers encounter various problems caused by polymorphism of the API and/or intermediate molecules that can affect the entire development of a drug candidate, many aspects of its manufacturing and commercialization, and even the life cycle and future of a drug after launch.
We are a leader in solid form screen and studies with extensive experience in form selection and development for more than 500 drug candidates. We tailor our service to meet your needs in different stages of the drug development utilizing our expertise and experience with various types of molecules. We design and maximize our screen space based on inputs from both simulation/prediction and experimental data. We deliver cost effective and timely solutions in alignment with development phase of your molecules through well-rationalized, detail-observant, and results-oriented screening. We provide a clear phase mapping and through solid understanding for your compounds using our expertise and experience.
We employ an integrated approach below to identify the most suitable solid-state form, including polymorph screening, salt screening, cocrystal screening and amorphous solid dispersion screening. For solid form evaluation, we utilize phase diagram to define the thermodynamic stability space of the selected solid form, which provides scientific guidance for successful drug substance and drug product developments. We utilize crystallography extensively to analyze and solve problems encountered in the course of API process research, development, and manufacturing. Crystallography provides not only precise measurements of structural information, such as absolute configuration and conformation, but also provides property insight that helps researchers devise solutions to problems encountered during processes such as purification via crystallization and formulation design.
- FDA Guidance for Industry: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
- FDA Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals Guidance for Industry
- ICH guideline: Investing the need to set acceptance criterial for polymorph in drug substances and drug products